GI Dynamics loses CE Mark certificate for EndoBarrier

GI Dynamics (ASX:GID) said yesterday that its notified body in Europe withdrew its certification for CE Mark approval for its EndoBarrier device, meaning the company can no longer sell the obesity and diabetes treatment in the European Union. CEO Scott Schorer told MassDevice.com today during a telephone interview that Boston-based GID passed an intensive, week-long inspection of its quality management system and was taken by surprise when SGS United Kingdom said Nov. 11 that it would withdraw the CE Mark effective Nov. 12. When the potential CE Mark suspension was announced in May the company said it would have six months to regain compliance. “We went through the annual ISO audit of our quality management system in May 2017. We subsequently went through a re-inspection, not only of the observations made in May but an expanded inspection to full ISO certification, as you would for a startup, and expanded the scope of inspection significantly from one-and-a-half days to almost seven days and we passed with only one minor observation,” Schorer told us today. “We think that the date’s wrong, it should be Nov. 17. We are trying to communicate with SGS to resolve this and provide information that we know satisfies SGS’s concerns.” Schorer also said the company is working on winning an investigational device exemption from the FDA and hopes to have it in hand during the first quarter next year. “In parallel to cleaning up our entire qual...
Source: Mass Device - Category: Medical Devices Authors: Tags: Diabetes Regulatory/Compliance Weight loss GI Dynamics Source Type: news